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Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2021 and Provides Corporate Update
Topline data from pivotal Phase 3 safety and efficacy study (NORSE TWO) on target to report in Q3 2021Topline data from the open-label safety study (NORSE
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Topline data from pivotal Phase 3 safety and efficacy study (NORSE TWO) on target to report in Q3 2021Topline data from the open-label safety study (NORSE THREE) on target to report in Q2 2021Recent funding significantly enhances financial position, extends cash runway through BLA filing and provides strategic optionality to maximize stockholder value MONMOUTH JUNCTION, N.J., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2020.Outlook Therapeutics also provided a clinical development and pre-commercialization update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications. “As we look forward to what we believe will be an exciting year at Outlook Therapeutics, I am proud of our team and the tremendous progress we have made, despite the challenges from the current pandemic. Outlook Therapeutics continues to advance ONS-5010 on multiple fronts as we work towards a BLA filing for ONS-5010 for wet AMD. On the clinical side, two of the three clinical trials for our planned BLA for wet AMD are now completed. With the cash proceeds received from our successful recent capital raise, we are now focused on the topline data readouts expected over the next two quarters, and completing the CMC work for the BLA submission, expected in December of this year,” commented Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “We believe we now have the necessary resources to support our continued development efforts as we evaluate our options for the best path forward to commercialize ONS-5010 and provide the greatest value to our stockholders.” Recent Corporate Highlights Secured aggregate gross proceeds in February 2021 of $42.6 million to support ONS-5010 / LYTENAVA™ providing funding through planned Biologics License Application (BLA) submission;Reported final visit for last patient in open-label safety study (NORSE THREE) of ONS-5010 / LYTENAVATM (bevacizumab-vikg) in February 20...